ACTiF- Assessment of Closed Tibial Fractures

NCT00533377

Last updated date
Study Location
Pfizer Investigational Site
Wichita, Kansas, 67214, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tibial Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
17 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury;

- Closed tibial fractures Types A, B & C (See OTA fracture classification) can be included.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Previous fractures of the same tibia that may impact nailing procedure or impaired
visibility of current fracture or a history of osteomyelitis;


- Subjects with any other clinically significant injuries, which may significantly
impair weight bearing of the affected limb;


- Subjects with a fracture gap of >1cm after initial surgery and prior to drug
administration;


- Any other planned invasive or non invasive interventions intended to promote bone
healing of the tibial fracture under study are not allowed in the first 24 weeks after
treatment.

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Tibial FracturesACTiF- Assessment of Closed Tibial Fractures NCT00533377
  1. Wichita, Kansas
  2. Worcester, Massachusetts
  3. Minneapolis, Minnesota
  4. Columbia, Missouri
  5. Durham, North Carolina
  6. Chattanooga, Tennessee
  7. Dallas, Texas
  8. Houston, Texas
  9. Salt Lake City, Utah
  10. Morgantown, West Virginia
  11. Morgantown, West Virginia
  12. Herston, Queensland
  13. Adelaide, South Australia
  14. Sarajevo,
  15. Red Deer, Alberta
  16. Red Deer, Alberta
  17. Hamilton, Ontario
  18. London, Ontario
  19. London, Ontario
  20. Ottawa, Ontario
  21. Sarnia, Ontario
  22. Sarnia, Ontario
  23. Sarnia, Ontario
  24. Sarnia, Ontario
  25. Sarnia, Ontario
  26. Sarnia, Ontario
  27. Sarnia, Ontario
  28. Toronto, Ontario
  29. Varazdin,
  30. Zagreb,
  31. Secunderabad, Andhra Pradesh
  32. Bangalore, Karnataka
  33. Bangalore, Karnataka
  34. Mangalore, Karnataka
  35. Mumbai, Maharashtra
  36. Ludhiana, Punjab
  37. Lucknow, UttarPradesh
  38. Nagoya-shi, Aichi-ken
  39. Kitakyushu-shi, Fukuoka-ken
  40. Mizumaki-cho Onga-gun, Fukuoka-ken
  41. Okawa-shi, Fukuoka-ken
  42. Fujisawa-shi, Kanagawa-ken
  43. Kouchi City, Kouchi-ken
  44. Sasebo-Shi, Nagasaki-ken
  45. Toda-shi, Saitama-ken
  46. Shinagawa-ku, Tokyo
  47. St. Petersburg,
  48. St. Petersburg,
  49. Parktown, Gauteng Province
  50. Glenwood, Kwazulu Natal
  51. Soweto,
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ALL GENDERS
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Tibial FracturesStudy Evaluating InductOs in Diaphyseal Tibia Fractures NCT00161616
  1. Gent,
  2. Turku,
  3. Creteil,
  4. Toulouse,
  5. Berlin,
  6. Mainz,
  7. Muenster,
  8. Pavia,
  9. Roma,
  10. Rotterdam,
  11. Bergen,
  12. Oslo,
  13. Bialystok,
  14. Lublin,
  15. Sosnowiec,
  16. Szczecin,
  17. Bucuresti,
  18. Bucuresti,
  19. Bucuresti,
  20. Bloemfontein,
  21. Cape Town,
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  24. Durban,
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  26. Bristol,
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ALL GENDERS
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years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE ACTiF- Assessment of Closed Tibial Fractures
Official Title  ICMJE A Randomized, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of CP-533,536 In Subjects With Closed Fracture Of The Tibial Shaft
Brief Summary The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing procedure
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tibial Fractures
Intervention  ICMJE
  • Drug: CP-533, 536
    Active study drug
  • Drug: Placebo
    Placebo vehicle
  • Procedure: Standard of Care
    Standard surgical procedure
  • Drug: CP-533,536
    Active study drug
Study Arms  ICMJE
  • Experimental: CP-533,536 Dose Level 2
    Intervention: Drug: CP-533, 536
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Standard of Care
    Intervention: Procedure: Standard of Care
  • Experimental: CP-533,536 Dose Level 1
    Intervention: Drug: CP-533,536
  • Experimental: CP-533,536 Dose Level 3
    Intervention: Drug: CP-533,536
  • Experimental: CP-533.536 Dose Level 4
    Intervention: Drug: CP-533,536
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2010)
276
Original Enrollment  ICMJE
 (submitted: September 20, 2007)
264
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury;
  • Closed tibial fractures Types A, B & C (See OTA fracture classification) can be included.

Exclusion Criteria:

  • Previous fractures of the same tibia that may impact nailing procedure or impaired visibility of current fracture or a history of osteomyelitis;
  • Subjects with any other clinically significant injuries, which may significantly impair weight bearing of the affected limb;
  • Subjects with a fracture gap of >1cm after initial surgery and prior to drug administration;
  • Any other planned invasive or non invasive interventions intended to promote bone healing of the tibial fracture under study are not allowed in the first 24 weeks after treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bosnia and Herzegovina,   Canada,   Croatia,   India,   Japan,   Russian Federation,   South Africa,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00533377
Other Study ID Numbers  ICMJE A3241010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP